Bayer Aktiengesellschaft

Bayer Healthcare LLC

Peter Schwan

Martin Lobedann

Ben Arlett

Jonathan David Tuckwell

Robert Owen Kivlin

Lee Wood

Benjamin Maiser

Robert Dyer

John Paul Palmer-Felgate

Matthew Burgess Avery

Kevin George Skinner

Chris Kadamus

Volker Möhrle

Laura David

Lutz-Peter Lenz

Nils Weber

Sven-Oliver Borchert

Kerstin Baumarth

Andrea Vester

Heiko Brandt

Jens Bernshausen

Disclosed herein is a method for validation of continuous viral clearance comprising the steps of providing a probe to be validated, spiking the probe in a valid manner, performing viral clearance, sampling the spiked probe and analyzing the sample of the spiked probe of step d).

Validation of continuous viral clearance

The invention provides a method for the continuous, microbe-reduced production and/or processing of a biopharmaceutical, biological macromolecular product from a heterogeneous cell culture-fluid mixture, comprising the steps of: (a) providing a particle-free fluid from a heterogeneous cell culture-fluid mixture containing the product, in the form of a product stream, (b) at least one filtration, providing a filtrate, (c) at least two chromatography steps for purifying the product, (d) at least one virus depletion, (e) at least one ultrafiltration and/or at least one diafiltration of the product stream of steps (b), (c) and/or (d), characterized in that the at least two chromatography steps from (c) comprise a purification via at least two chromatography columns and/or membrane adsorbers in each case and that the process is carried out in a closed and modular manner The invention further provides a corresponding modular system for carrying out said method.

Modular system and process for the continuous, microbe-reduced production and/or processing of a product

The invention provides a method for continuous virus inactivation. The product stream is segmented by introducing a separating medium which is immiscible with the product stream and the segmented product stream is transported into a reactoras detention segment under virus-inactivating conditions for the required detention time.

Method for continuous virus inactivation

The invention relates to an ultrafiltration unit for continuous buffer or medium exchange, a method for continuous buffer or medium exchange in the ultrafiltration unit, and a plant in particular for (semi)continuous production of biopharmaceutical and biological macromolecular products in particular, such as proteins, e.g. monoclonal antibodies and vaccines, comprising the ultrafiltration unit according to the invention.

Ultrafiltration unit for continuous buffer or medium exchange from a protein solution

A reconstitution device having an opening surrounded by a neck, and a cap including a first end, a second end, and an inner bore having a central aperture. A stopper is positioned in the opening of the neck and includes a portion capable of being perforated. A plunger is located at the second end of the cap, is configured to slide along the inner bore of the cap, and includes a shaft extending downwardly in a direction towards the stopper and having a pointed end for piercing the stopper. A locking mechanism is located in the cap and includes an aperture. The locking mechanism is configured such that when the plunger is pushed downwardly the shaft is allowed to pass through the aperture, but when the plunger is pulled upwardly the second aperture changes shape such that the shaft cannot freely pass through the aperture.

Reconstitution device

A reconstitution device for storing a first component of a pharmaceutical preparation includes a receptacle, a cap having a first end secured to the receptacle, a second end, and an inner bore having a central aperture. The device further includes a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated. The device also includes a plunger secured to the second end of the cap, a locking mechanism located in the cap, and an actuating mechanism. The actuating mechanism may prevent the device from inadvertent activation.

Growing community of inventors

Leverkusen, Germany

Peter Schwan